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New therapy aims to ease PTSD in new moms after traumatic birth

NCT ID NCT04916938

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a therapy called Interaction Guidance Therapy (IGT) for mothers with post-traumatic stress disorder (PTSD) after a traumatic pregnancy or childbirth. The therapy uses video feedback to help mothers become more sensitive to their baby's cues. Researchers will compare IGT to usual care in 36 mothers, measuring stress levels and mother-baby interaction at 3 months and 1 year after birth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Interaction Guidance Therapy (video feedback therapy)
What this could lead to
If it works, this could offer a short-term therapy to help mothers with postnatal PTSD feel less stressed and bond better with their baby.
What could go wrong
This is a small, early study with only 36 participants, so results may not apply to everyone. The therapy may not reduce symptoms more than usual care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Dec 2021

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For the mother: 1. Mother over 18 years old, who gave birth to a healthy child 2. Mother having a PCL-5 score higher than \> 31, 5 +/- 1 week after delivery and the traumatic event is related to childbirth or pregnancy. 3. Mother Speaking and reading French, 4. Mother with signed consent 5. Mother with rights open to social security 6. Mother and Father consent to the participation of the baby For the father: 1. holder of parental authority 2. Speaking and reading French 3. Consent to self-reported questionnaires Exclusion Criteria 1. PTSD not related to pregnancy or birth. 2. Child's health situation who impact the feasibility of the protocol, with a risk of hospitalization of more than 3 days between 6 and 12 weeks of life 3. Childbirth under 34 weeks of gestational age 4. Twins 5. Stillbirth 6. Any mother's acute, somatic or psychiatric clinical condition not compatible with the research procedure

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Conditions

The condition(s) this trial relates to.

post-traumatic stress disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post traumatic stress disorder PTSD

Contacts and locations

Locations

  • CHRU Reims

    Reims, 51000, France

  • CHU - Maternité

    Besançon, 25000, France

  • CHU Besançon

    Besançon, 25 000, France

  • Centre hospitalier - unité de périnalité

    Reims, 51100, France

  • Centre hospitalier Intercommunal André Grégoire

    Montreuil, 93100, France

  • Centre hospitalier Saint Anne

    Paris, 75014, France

  • Etablissement Ville Evrard

    Noisy-le-Sec, 93130, France

  • Hôpital Necker - Enfants malades - pedospychiatrie

    Paris, 75015, France

  • Hôpital Necker - Maternity

    Paris, 75015, France

  • Hôpital Saint Joseph - Maternité

    Paris, 75014, France

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